FDA Status Report Medical Devices Single Audit Programme

Recommendation

31 May / 1 June 2023
Heidelberg, Germany

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A programme led by the FDA is currently running in the area of medical devices: the Medical Devices Single Audit Programme (MDSAP). An interim report of the FDA shows the current status and the further steps. The objective of the pilot study is to show that an audit of a medical device manufacturer conducted by an MDSAP recognised auditing organisation can replace audits from diverse authorities.

The report lists the auditing organisations (AO) involved in the programme and their respective auditing status within the pilot programme. Interestingly, the requirements on AOs have even been tightened during the pilot project. Initially, one prerequisite witnessed audit was planned to be recognised as an AO; now it is three.

In the report, a table presents the objectives and their implementation which have to be achieved within the pilot programme. Those are for example programme performance indicators, targets and metrics. For the MDSAP there is an independent procedure which includes provisions with regard to complaints, feedback, proceeding regarding different opinions and CAPA. The pilot phase should be successfully achieved by the end of 2016. Whereby some data material is still missing - the number of voluntary companies might be higher. As of 2017, the programme should be open to further AOs.

For further details please see the Medical Devices Single Audit Program (MDSAP) Mid-Pilot Status Report.